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FILGRASTIM ALONE OR IN COMBINATION W/ R METHUSCF IN BREAST CANCER

FILGRASTIM ALONE OR IN COMBINATION W/ R METHUSCF IN BREAST CANCER
单独使用 FILGRASTIM 或与 METHUSCF 联用治疗乳腺癌
批准号：
6263870
负责人：
Thomas C. Shea
金额：
$0.02万
依托单位：
UNIV OF NORTH CAROLINA CHAPEL HILL
依托单位国家：
美国
项目类别：
财政年份：
1998
资助国家：
美国
项目状态：
已结题
起止时间：
1998-12-01 至 1999-11-30
来源：
https://reporter.nih.gov/project-details/6263870
关键词：
CD34 molecule breast neoplasms clinical research clinical trial phase I colony stimulating factor combination chemotherapy female hematopoietic growth factor hematopoietic stem cells human subject human therapy evaluation neoplasm /cancer chemotherapy

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中文摘要
翻译
本研究的目的是与单用大剂量非格列辛相比，联合应用r-metHuSCF和大剂量非格列辛来提高CD34+细胞的动员能力。1.比较造血祖细胞(CD34+细胞)在第5天、第6天和第7天采集的总的3天总产率，分别使用20微克/公斤/天和30微克/公斤/天的r-metHuSCF与30微克/公斤/天的非格列汀和30微克/公斤/天的福格替姆。2.比较采集的CD34+细胞/公斤的日产量。比较患者达到临床相关PBPC产量的比例(例如，1×10^6和5×10^6 CD34+细胞/公斤)4.评估r-metHuSCF与大剂量非格雷替合用的安全性
英文摘要
The purpose of this study is to improve mobilization of CD34+ cells with r-metHuSCF in combination with high-dose Filgrastim as compared to high-dose Filgrastim alone. 1. To compare the total 3 day yield of hematopoietic progenitor cells (CD34+ cells) collected on days 5, 6 and 7, using either 20 ug/kg/day r-metHuSCF in combination with 30 ug/kg/day of Filgrastim or 30 ug/kg/day Fugrastim alone 2. To compare the daily yield of CD34+ cells/kg collected 3. To compare the proportion of patients reaching clinically relevant PBPC yields (eg, 1 x 10^6 and 5 x 10^6 CD34+ cells/kg) 4. To assess the safety of r-metHuSCF in combination with high-dose Filgrastim
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CORE--PROTOCOL REVIEW AND MONITORING SYSTEM
FILGRASTIM ALONE OR IN COMBINATION W/ R METHUSCF IN BREAST CANCER
PHARMACODYNAMIC MODELING OF ORAL ETOPOSIDE IN RELAPSED NON HODGKINS
PHARMACODYNAMIC MODELING OF ORAL ETOPOSIDE IN RELAPSED NON HODGKINS
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